• Number of cases: 1403 (3.3% of the total PM dataset), of which
241 are medically confirmed and 1162 are non-medically
confirmed;
• Country of incidence: UK (268), US (233), Mexico (196), Italy
(141), France (128), Germany (102), Spain (46), Greece (45),
Portugal (37), Sweden (20), Ireland (17), Poland (16), Israel (13),
Austria, Romania and Finland (12 each), Netherlands (11),
Belgium and Norway (10 each), Czech Republic (9), Hungary and
Canada (8 each), Croatia and Denmark (7 each), Iceland (5); the
remaining 30 cases were distributed among 13 other countries;
• Subjects’ gender: female (1076), male (291) and unknown (36);
• Subjects’ age group (n = 1346): Adultc (1078), Elderlyd (266)
Child e and Adolescentf (1 each);
• Number of relevant events: 1441, of which 946 serious, 495
non-serious; in the cases reporting relevant serious events;
• Reported relevant PTs: Tachycardia (1098), Arrhythmia (102),
Myocardial infarction (89), Cardiac failure (80), Acute myocardial
infarction (41), Cardiac failure acute (11), Cardiogenic shock and
Postural orthostatic tachycardia syndrome (7 each) and Coronary
artery disease (6);
• Relevant event onset latency (n = 1209): Range from <24 hours to
21 days, median <24 hours